BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELIMED WASHER/DISINFECTOR WD290

    MDR report key: 14670707 · Received June 11, 2022

    Report

    Report Number
    3001061128-2022-00011
    Event Type
    Malfunction
    Date Received
    June 11, 2022
    Report Date
    June 11, 2022
    Manufacturer
    BELIMED AG
    Product Code
    MEC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WASHER/DISINFECTORS ARE DELIVERED TO A HEALTHCARE FACILITY WITH A CERTAIN NUMBER OF PREPROGRAMMED COMMON REPROCESSING CYCLES THAT MAY BE MODIFIED BY A BELIMED TECHNICIAN DURING INSTALLATION OF THE DEVICE AT THE FACILITY OR THEREAFTER IN ACCORDANCE WITH USER NEEDS. HOWEVER, USER MODIFICATION OF REPROCESSING CYCLES AS NEEDED FOR SPECIFIC ITEMS REQUIRING CLEANING AND DISINFECTION IS ALSO POSSIBLE. THE DEVICE MANUAL INCLUDES DETAILED INSTRUCTIONS FOR SUCH ADJUSTMENTS. THESE INSTRUCTIONS WERE NOT FOLLOWED WHEN THE DISINFECTION CYCLE WAS MODIFIED BY THE THIRD PARTY TECHNICIAN.THE EVENT OCCURRED NEAR THE END OF 2019 OR IN EARLY 2020. ALL WASHER/DISINFECTORS HAVE BEEN RUNNING AT FULL CAPACITY SINCE THEN. THE DEFICIENTLY PARAMETERIZED "GENERAL INSTRUMENTS" CYCLE WAS THE MOST FREQUENTLY RUN PROGRAM, BUT NOT THE ONLY ONE. ALL THE OTHER PROGRAMS WERE EXECUTED CORRECTLY.THE ERROR WAS DETECTED RECENTLY BY A BELIMED TECHNICIAN WHO HAD BEEN CALLED IN BY THE FACILITY TO FIX AN UNRELATED, NON-REPORTABLE PROBLEM WITH REPROCESSING PARAMETERS AGAIN MODIFIED DEFICIENTLY BY A THIRD-PARTY TECHNICIAN EMPLOYED BY THE HEALTHCARE FACILITY'S CHOSEN DETERGENT MANUFACTURER. BELIMED PROCEEDED TO CHECK ALL WASHER/DISINFECTORS AND DISCOVERED THE ERROR THAT IS BEING REPORTED IN THIS MEDICAL DEVICE REPORT.BELIMED HAS CORRECTED THE PARAMETERS OF THE AFFECTED PROGRAM TO CARRY OUT THE DISINFECTION STEP IN CONFORMANCE WITH DEVICE SPECIFICATIONS AND USER NEEDS. THE PROGRAM IS NOW RUNNING CORRECTLY.

    Description of Event or Problem · 0

    THE DISINFECTION PARAMETERS OF A WASHER/DISINFECTOR PROGRAM WERE CHANGED AT A HEALTHCARE FACILITY BY A THIRD PARTY TECHNICIAN EMPLOYED BY THE FACILITY'S CHOSEN DETERGENT MANUFACTURER. THE FACILITY'S INTENTION WAS TO SHORTEN THE TOTAL DURATION OF THE REPROCESSING CYCLE BY ELEVATING THE TEMPERATURE FOR DISINFECTION AND CUTTING BACK THE TIME. HOWEVER, THE DISINFECTION STEP WAS ERRONEOUSLY SET TO "FLUSH" INSTEAD OF "DISINFECT." THE CHANGE RESULTED IN OMISSION OF THE DISINFECTION CYCLE. THE INCORRECT PARAMETERS WERE THEN COPIED TO TEN ADDITIONAL WASHER/DISINFECTORS AT THE SAME HEALTHCARE FACILITY. THE AFFECTED "GENERAL INSTRUMENTS" REPROCESSING CYCLE IS INTENDED FOR CLEANING, THERMAL DISINFECTION AND DRYING OF THERMOSTABLE SURGICAL INSTRUMENTS. DISINFECTION PERFORMANCE WAS AFFECTED BY THE EVENT, RESULTING IN NON-COMPLIANCE WITH BELIMED'S DISINFECTION SPECIFICATION --AN A0 VALUE OF 3000-- WHEN THE PROGRAM WAS SUBSEQUENTLY RUN BY THE USER. PATIENTS WERE NOT AT RISK AT ANY TIME THROUGHOUT THE PERIOD DURING WHICH THE DEFICIENTLY PARAMETERIZED CYCLE WAS RUN AT THE FACILITY. THE PATIENT-RELEVANT REPROCESSING STEPS OF THE AFFECTED PROGRAM ARE CLEANING AND DRYING, WHICH FUNCTIONED CORRECTLY AT ALL TIMES. IN ADDITION, THE OVERALL REPROCESSING PROCEDURE FOR THERMOSTABLE SURGICAL INSTRUMENTS ALWAYS INCLUDES STEAM STERILIZATION AS THE FINAL MICROBICIDAL STEP. THE DISINFECTION STEP OF THE PROGRAM IS INTENDED TO PROTECT THE USER. LACK OF DISINFECTION MAY PUT USER HEALTH AT RISK BY CONTACT WITH CLEAN BUT NON-DISINFECTED INSTRUMENTS DURING THE PROCESS OF EMPTYING THE WASHER AND PREPARING THE INSTRUMENTS FOR STERILIZATION, PARTICULARLY IF THE USER IS NOT WEARING PERSONAL PROTECTIVE EQUIPMENT. SINCE THE FAULTY DISINFECTION STEP WAS COPIED TO 10 ADDITIONAL DEVICES, THIS IS REPORT #11 OF ELEVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2810487 BELIMED WASHER/DISINFECTOR WD290 WASHER/DISINFECTOR MEC BELIMED AG WD290 994031044016

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other